InfertilityNCT04496284
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
A study testing Vitrification via slush nitrogen in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Vitrification via slush nitrogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Major Inclusion Criteria for participants:
- Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
- Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
- Couples electing single embryo transfer (SET)
Major Exclusion Criteria for participants:
- All patients who do not voluntarily give their written consent for participation
- Under 18 years old, above 42 years old
- BMI > 35
- Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
- Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
- Total basal antral follicle count less than 6 follicles
- Failed more than one previous FET cycle
- Use of oocyte donation
- Use of gestational carrier
- Presence of hydrosalpinges that communicate with endometrial cavity
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
- Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
- Sex selection
- Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.
Read the detailed description
The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.
- Conditions
- Infertility
- Being tested
- Vitrification via slush nitrogen
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrification via slush nitrogenOther
blastocyst stage embryos will be vitrified via slush nitrogen
| Study group | Role | What they receive |
|---|---|---|
| Vitrification via slush nitrogen | Experimental | Blastocyst stage embryos will be vitrified via slush nitrogen Receives: Other: Vitrification via slush nitrogen |
| Vitrification via liquid nitrogen | No intervention | Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained implantation rate
fetal heart beat present upon discharge at 8 weeks
Measured: approximately 8 weeks gestation age
Secondary outcomes (3)
clinical pregnancy rate
presence of gestational sac in uterus
Measured: usually by 5 weeks gestational age
miscarriage rate
pregnancy loss
Measured: 1-8 months dependent on gestational age of loss
live birth rate
delivery of live infant
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start5 Sep 2020
- Primary completion3 May 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496284
- Sponsor's protocol ID
- RMA-2020-03
- Status last verified
- May 2023
- First submitted
- 28 Jul 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klimczak AM, Osman E, Esbert M, Yildirim RM, Whitehead C, Herlihy NS, Hanson BM, Roberts LM, Seli E, Scott RT Jr. A randomized controlled trial comparing embryo vitrification with slush nitrogen to liquid nitrogen in women undergoing frozen embryo transfer: embryology and clinical outcomes. Hum Reprod. 2025 Mar 1;40(3):426-433. doi: 10.1093/humrep/deaf003.
PubMed 39836897
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
- ClinicalTrials.gov ID
- NCT04496284
- Acronym / sponsor ID
- RMA-2020-03
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.
Detailed description
The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrification via slush nitrogen | Experimental | Other: Vitrification via slush nitrogenBlastocyst stage embryos will be vitrified via slush nitrogen |
| Vitrification via liquid nitrogen | No intervention | –Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitrification via slush nitrogenblastocyst stage embryos will be vitrified via slush nitrogen | Other | Vitrification via slush nitrogen |
Primary outcome
sustained implantation rate
Time frame: approximately 8 weeks gestation age
fetal heart beat present upon discharge at 8 weeks
3 secondary outcomes
clinical pregnancy rate
Time frame: usually by 5 weeks gestational age
miscarriage rate
Time frame: 1-8 months dependent on gestational age of loss
live birth rate
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 39836897Klimczak AM, Osman E, Esbert M, Yildirim RM, Whitehead C, Herlihy NS, Hanson BM, Roberts LM, Seli E, Scott RT Jr. A randomized controlled trial comparing embryo vitrification with slush nitrogen to liquid nitrogen in women undergoing frozen embryo transfer: embryology and clinical outcomes. Hum Reprod. 2025 Mar 1;40(3):426-433. doi: 10.1093/humrep/deaf003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrification via slush nitrogen in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained implantation rate (time frame: approximately 8 weeks gestation age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.